00-004310PL Department Of Health, Board Of Pharmacy vs. Marlene Bass, R.Ph. Status: Closed Recommended Order on Tuesday, March 13, 2001.

Summary: Proof was insufficient to clearly and convincingly establish that licensed pharmacist misfilled a prescription on two occasions, as alleged in the Administrative Complaint.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

PHARMACY, )

)

Petitioner, )

)

vs. ) Case No. 00- 4310PL

)

MARLENE BASS, R.PH ., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a hearing was held in this case in

accordance with Section 120.57(1), Florida Statutes, on

December 28, 2000, by video teleconference at sites in West

Palm Beach and Tallahassee, Florida, before Stuart M. Lerner,

a duly-designated Administrative Law Judge of the Division of

Administrative Hearings.

APPEARANCES

For Petitioner : Lawrence F. Kranert, Jr., Esquire

Agency for Health Care Administration

2727 Mahan Drive

Tallahassee, Florida 32308

For Respondent : Marlene Bass, R.Ph., pro se

3000 North Ocean Drive, No. 9G

Riviera Beach, Florida 33404

STATEMENT OF THE ISSUES

Whether Respondent committed the violation alleged in the

Administrative Complaint, and, if so, what disciplinary action

should be taken against her.

PRELIMINARY STATEMENT

On August 23, 2000, Petitioner filed an Administrative

Complaint against Respondent, a Florida-licensed pharmacist,

alleging that Respondent engaged in the following conduct and

thereby violated Section 465.016(1)(g), Florida Statutes:

On June 18, 1998 a prescription was

presented to Respondent to be filled for an

eighty year old female patient. The

prescription called for Thyroid #30, 15

milligrams each. In lieu of that

prescribed by the treating physician[,] the

Respondent dispensed fifteen (15) pills on

June 18, 1998, and fifteen (15) pills on

June 29, 1998, each of [which] contained

180 milligram[] dosages of Thyroid.

Through the submission of a completed Election of Rights

form dated September 20, 2000, Respondent " dispute[d]

the . . . allegations of fact contained in the Administrative

Complaint" and requested "a hearing involving disputed issues

of material fact, pursuant to Section 120.569 and 120.57(1),

Florida Statutes, before an administrative law judge appointed

by the Division of Administrative Hearings." On October 19,

2000, the matter was referred to the Division of

Administrative Hearings (Division) for the assignment of a

Division Administrative Law Judge to conduct the hearing

Respondent had requested.

On December 14, 2000, Petitioner filed a Motion to

Relinquish Jurisdiction in the instant case, arguing that

there " remain[ ed] no disputed issues of material fact." In

its motion, Petitioner conceded that "[a ] nother pharmacist

separate and apart from the Respondent filled the June 29

prescription [referred to in the Administrative Complaint]."

On December 27, 2000, following a motion hearing held by

telephone conference call, an Order was issued denying

Petitioner's Motion to Relinquish Jurisdiction.

As noted above, the final hearing was held on

December 28, 2000. Three witnesses testified at the hearing :

Anthony Lamattina, Respondent, and David Dimon. In addition

to the testimony of these three witnesses, one exhibit,

Petitioner's Exhibit 1, was offered and received into

evidence.

At the close of the evidentiary portion of the hearing,

the undersigned established a deadline (15 days from the date

of the filing of the hearing transcript with the Division) for

the filing of proposed recommended orders.

A transcript of final hearing (consisting of one volume)

was filed with the Division on February 19, 2001. Respondent

filed a proposed recommended order on January 8, 2001. To

date, Petitioner has not filed any post-hearing submittal.

FINDINGS OF FACT

Based upon the evidence adduced at the final hearing and

the record as a whole, the following findings of fact are

made:

1. Respondent is now, and has been since 1976, a

Florida-licensed pharmacist.

2. At all times material to the instant case, Respondent

was employed by Eckerd Corporation as one of two full-time

pharmacists assigned to the Eckerd Drug Store (Store Number

3372) located at 312 North Lake Boulevard in North Palm Beach,

Florida, which housed a community pharmacy that was open 14

hours a day.

3. Respondent and the store's other full-time pharmacist

worked separate, alternating shifts.

4. At the beginning of each shift, Respondent "signed

on" the pharmacy's computer system. She "logged off" the

system at the end of the shift.

5. Respondent was responsible for the supervision of all

activities in the pharmacy during her shift.

6. Among the activities it was her responsibility to

supervise were those engaged in by the pharmacy technician on

duty.

7. The pharmacy technician assisted Respondent by, among

other things, preparing computer-generated prescription labels

and customer receipts for prescriptions that needed to be

filled. The technician prepared these items by entering the

required information, including the name and strength of the

prescribed medication, into the pharmacy's computer

system. 1/

8. All prescription labels and customer receipts

prepared by the pharmacy technician on duty during

Respondent's shift contained Respondent's initials (" MCB").

9. After they were prepared, the prescription labels and

customer receipts were placed in bags, and the bags were put

in baskets on the counter near Respondent, where they remained

until the prescriptions were filled.

10. When filling a prescription, it was Respondent's

practice to examine the actual prescription written by the

prescribing physician or, in the case of an oral prescription,

the pharmacy's written record of such prescription, to confirm

the accuracy of the prescription information on the

prescription label and customer receipt and to make sure that

she was dispensing what the physician had prescribed. 2/

11. The pharmacy was a "very busy" one. As a result, at

the end of her shift, there were sometimes prescriptions for

which labels and receipts (bearing her initials) had been

prepared, but which Respondent had not had the opportunity to

fill, and it was not until the following shift, when she was

off duty, that these prescriptions were actually filled.

12. Respondent was on duty on June 18, 1998, when a

computer-generated prescription label and customer receipt for

a prescription (Prescription Number 6071853) for Patient H. V.

were prepared. The computer-generated prescription label and

customer receipt, which had Respondent's initials on them,

indicated, among other things, that the prescription was for

15 180 milligram tablets of Thyroid and that the prescribing

physician was Dr. H. Pomeranz.

13. It is unclear when, and by whom, Prescription Number

6071853 was filled.

14. On or about October 9, 1998, Patient H. V.'s son,

R. V., filed a complaint with Petitioner alleging that "the

prescription [his mother] was suppose[d] to [have] be[en]

taking was 15 mil[ li]grams," but she instead "was given 180

mil[ lli]grams per day by [the] Eckerd Drug Store [on North

Lake Boulevard]."

15. David Dimon, a Medical Malpractice Investigator with

the Agency for Health Care Administration, investigated the

complaint.

16. As part of his investigation, Mr. Dimon contacted

Respondent, who advised him that she did not want to make a

statement regarding the complaint.

17. Mr. Dimon also spoke with the prescribing physician,

Dr. Pomeranz, who told him that she "prescribed Thyroid, 15

milligrams, for the patient, and not the 180 milligram dose

given by Eckerd Pharmacy." 3/ Dr. Pomeranz further indicated

to Mr. Dimon that H. V. 4/ suffered "side effects" as a

result of taking the 180 milligram tablets.

CONCLUSIONS OF LAW

18. Petitioner is statutorily empowered to take

disciplinary action against Florida-licensed pharmacists based

upon any of the grounds enumerated in Section 465.016(1),

Florida Statutes. Such disciplinary action may include one or

more of the following penalties : license revocation; license

suspension; imposition of an administrative fine not to exceed

$5,000 for each count or separate offense; issuance of a

reprimand; and placement on probation for a period of time and

subject to such conditions as the Board may specify,

including, but not limited to, requiring the licensee to

submit to treatment, to attend continuing education courses,

to submit to reexamination, or to work under the supervision

of another licensee. Section 465.016(2), Florida Statutes.

19. A license that has been suspended or revoked may not

be " reinstate[d] . . . until such time as [Petitioner] is

satisfied that [the disciplined licensee] has complied with

all the terms and conditions set forth in the final order and

that the [licensee] is capable of safely engaging in the

practice of pharmacy." Section 465.016(3), Florida Statutes.

20. Section 465.016(1)(g), Florida Statutes, authorizes

Petitioner to take disciplinary action against a licensed

pharmacist for "[u ]sing in the compounding of a prescription,

or furnishing upon prescription, an ingredient or article

different in any manner from the ingredient or article

prescribed, except as authorized in s. 465.019(6) or s.

465.025." 5/

21. "No revocation [or] suspension . . . of any

[pharmacist's] license is lawful unless, prior to the entry of

a final order, [Petitioner] has served, by personal service or

certified mail, an administrative complaint which affords

reasonable notice to the licensee of facts or conduct which

warrant the intended action and unless the licensee has been

given an adequate opportunity to request a proceeding pursuant

to ss . 120.569 and 120.57." Section 120.60(5), Florida

Statutes.

22. The licensee must be afforded an evidentiary hearing

if, upon receiving such written notice, the licensee disputes

the alleged facts set forth in the administrative complaint.

Sections 120.569(1) and 120.57, Florida Statutes.

23. At the hearing, Petitioner bears the burden of

proving that the licensee engaged in the conduct, and thereby

committed the violations, alleged in the administrative

complaint. Proof greater than a mere preponderance of the

evidence must be presented. Clear and convincing evidence of

the licensee's guilt is required. See Department of Banking

and Finance, Division of Securities and Investor Protection v.

Osborne Stern and Company , 670 So. 2d 932, 935 (Fla. 1996) ;

Ferris v. Turlington , 510 So. 2d 292 (Fla. 1987) ; Pou v.

Department of Insurance and Treasurer , 707 So. 2d 941 (Fla. 3d

DCA 1998); and Section 120.57(1)(j), Florida Statutes

("Findings of fact shall be based upon a preponderance of the

evidence, except in penal or licensure disciplinary

proceedings or except as otherwise provided by

statute . . . .").

24. Clear and convincing evidence "requires more proof

than a 'preponderance of the evidence' but less than 'beyond

and to the exclusion of a reasonable doubt.'" In re Graziano ,

696 So. 2d 744, 753 (Fla. 1997). It is an "intermediate

standard." Id. For proof to be considered "'clear and

convincing' . . . the evidence must be found to be credible;

the facts to which the witnesses testify must be distinctly

remembered; the testimony must be precise and explicit and the

witnesses must be lacking in confusion as to the facts in

issue. The evidence must be of such weight that it produces

in the mind of the trier of fact a firm belief or conviction,

without hesitancy, as to the truth of the allegations sought

to be established." In re Davey , 645 So. 2d 398, 404 (Fla.

1994), quoting, with approval, from Slomowitz v. Walker , 429

So. 2d 797, 800 (Fla. 4th DCA 1983).

25. In determining whether Petitioner has met its burden

of proof, it is necessary to evaluate its evidentiary

presentation in light of the specific factual allegations made

in the administrative complaint. Due process prohibits an

agency from taking disciplinary action against a licensee

based upon conduct not specifically alleged in the agency's

administrative complaint or other charging instrument. See

Hamilton v. Department of Business and Professional

Regulation , 764 So. 2d 778 (Fla. 1st DCA 2000) ; Lusskin v.

Agency for Health Care Administration , 731 So. 2d 67, 69 (Fla.

4th DCA 1999); and Cottrill v. Department of Insurance , 685

So. 2d 1371, 1372 (Fla. 1st DCA 1996).

26. Furthermore, "the conduct proved must legally fall

within the statute or rule claimed [in the administrative

complaint] to have been violated." Delk v. Department of

Professional Regulation , 595 So. 2d 966, 967 (Fla. 5th DCA

1992). In deciding whether "the statute or rule claimed to

have been violated" was in fact violated, as alleged by

Petitioner, if there is any reasonable doubt, that doubt must

be resolved in favor of the licensee. See Whitaker v.

Department of Insurance and Treasurer , 680 So. 2d 528, 531

(Fla. 1st DCA 1996) ; Elmariah v. Department of Professional

Regulation, Board of Medicine , 574 So. 2d 164, 165 (Fla. 1st

DCA 1990); and Lester v. Department of Professional and

Occupational Regulations , 348 So. 2d 923, 925 (Fla. 1st DCA

1977).

27. Petitioner has alleged in the Administrative

Complaint issued in the instant case that Respondent violated

Section 465.016(1)(g), Florida Statutes, on June 18, 1998, and

again on June 29, 1998, by dispensing 15 180 milligram Thyroid

pills, when the prescriptions she was given to fill on those

two occasions "called for" 30 15 milligram pills of Thyroid.

28. To meet its burden of proving that Respondent

violated Section 465.016(1)(g), Florida Statutes, as alleged

in the Administrative Complaint, Petitioner had to clearly and

convincingly establish, through its proof at hearing, that

Respondent filled the two prescriptions referenced in the

Administrative Complaint (which hereinafter will be referred

to as the "June 18 prescription" and the "June 29

prescription") and that she did so in a manner that deviated

from the requirements of the prescriptions.

29. Petitioner made no attempt, at hearing, to prove

that Respondent had misfilled the June 29 prescription,

Petitioner having conceded prior to hearing (in its Motion to

Relinquish Jurisdiction) that "[a ] nother pharmacist separate

and apart from the Respondent [had] filled the June 29

prescription."

30. While it did pursue the charge made in the

Administrative Complaint concerning the filling of the June 18

prescription, its proof fell short of that necessary to

establish Respondent's guilt of the violation charged.

31. To prove that Respondent was the pharmacist that had

filled the June 18 prescription, Petitioner presented evidence

establishing that Respondent was one of the pharmacists on

duty at Eckerd Drug Store Number 3372 on June 18, 1998, and

that her initials were on the label and customer receipt that

the store's computer system had generated for the prescription

that day. Such evidence, however, does not clearly and

convincingly establish that it was Respondent (as opposed to

the pharmacist who worked the following shift) who filled the

June 18 prescription. See Nelms v. Walgreen Co. , 1999 WL

462145 (Tenn. App. 1999)("Plaintiff argues that, from this

evidence, a jury could have inferred that Walgreen Company's

representatives engaged in fraudulent conduct in an attempt to

conceal the fact that a pharmacy technician, and not Daniel

[the pharmacist whose initials were on the prescription

label], filled Inez Nelms ' prescription. We conclude that

this argument is without merit. Although a jury could have

found from the foregoing evidence that Ed Daniel was not the

pharmacist who filled Inez Nelms' prescription, such a finding

would not necessarily lead to the inference that a pharmacy

technician rather than a pharmacist filled the prescription.

Steve Presson, the pharmacist who was scheduled to work from

1:00 p.m. to 10:00 p.m. on October 2, 1995, testified that

either he or Daniel was the pharmacist on duty when the

prescription was filled. Thus, the Plaintiff's proof

presented two equally probable scenarios : that a pharmacy

technician filled the prescription in Ed Daniel's absence and,

alternatively, that Steve Presson filled the prescription.

Inasmuch as the proof failed to establish that one of these

conclusions was more probable than the other, we hold that

this proof cannot constitute clear and convincing evidence

that Walgreen Company's representatives fraudulently concealed

the fact that a pharmacy technician filled Inez Nelms'

prescription."). Indeed, Petitioner's own witness, Anthony

Lamattina , an Eckerd Corporation pharmacist who testified as

to the standard operating procedures followed in Eckerd Drug

Stores, was unable, with any degree of confidence, to

conclude, based upon the presence of Respondent's initials on

the computer-generated label and customer receipt for the June

18 prescription, that the prescription had been filled by

Respondent. 6/

32. Not only did Petitioner fail to prove that it was

Respondent who had filled the June 18 prescription, Petitioner

also failed to prove that the prescription had been misfilled.

To show that the prescription had been misfilled, it was

necessary for Petitioner, as a threshold requirement, to

establish, by clear and convincing evidence, what the

prescription actually "called for." The only proof it

submitted concerning the actual contents of the prescription

was the testimony of Mr. Dimon concerning what Dr. Pomeranz

had told him about the prescription. Petitioner did not offer

the prescription into evidence, nor did it present the

testimony of Dr. Pomeranz. Mr. Dimon's testimony constitutes

hearsay evidence 7/ that would not be admissible over

objection in a civil proceeding in Florida, and it therefore,

standing alone, is insufficient to support a finding

concerning the contents of the June 18 prescription. See

Department of Environmental Protection v. Department of

Management Services, Division of Administrative Hearings , 667

So. 2d 369, 370 (Fla. 1st DCA 1995) ; Sublett v. Sumter County

School Board , 664 So. 2d 1178 (Fla. 5th DCA 1995) ; Doyle v.

Florida Unemployment Appeals Commission , 635 So. 2d 1028,

(Fla. 2d DCA 1994) ; Scott v. Department of Professional

Regulation , 603 So. 2d 519 (Fla. 1st DCA 1992) ; Forehand v.

School Board of Gulf County , 600 So. 2d 1187, 1191-92 (Fla.

1st DCA 1992) ; Department of Administration, Division of

Retirement v. Porter , 591 So. 2d 1108, 1109 (Fla. 2d DCA

1992) ; Doran v. Department of Health and Rehabilitative

Services , 558 So. 2d 87, 88 (Fla. 1st DCA 1990) ; Johnson v.

Department of Health and Rehabilitative Services , 546 So. 2d

741 (Fla. 1st DCA 1989); and Section 120.57(1)(c), Florida

Statutes ("Hearsay evidence may be used for the purpose of

supplementing or explaining other evidence, but it shall not

be sufficient in itself to support a finding unless it would

be admissible over objection in civil actions."); see also

Keefover v. Giant Food, Inc. , 574 A.2d 339 ( Md. App.

1990)( "Judge Levin, in sustaining objections by Giant, said:

'I am not going to let you get in any evidence as of right now

of anything that Dr. Ein prescribed for this lady [Ms.

Keefover , the plaintiff in this action involving the alleged

negligent filling of a prescription]. It's that simple.' We

believe the trial court was correct. The statements allegedly

made by Dr. Ein are clearly hearsay insofar as Keefover's

claim against Giant is concerned.").

33. Inasmuch as the record evidence does not clearly and

convincingly establish that Respondent misfilled either the

June 18 prescription or the June 29 prescription, the

Administrative Complaint issued against Respondent, which

alleges that she engaged in such professional misconduct, must

be dismissed.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions

of Law, it is hereby

RECOMMENDED that the Board enter a final order dismissing

the Administrative Complaint issued against Respondent in its

entirety.

DONE AND ENTERED this 13th day of March, 2001, in

Tallahassee, Leon County, Florida.

___________________________________

STUART M. LERNER

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488- 9675 SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 13th day of March, 2001.

ENDNOTES

1/ Rule 64B16-27.410, Florida Administrative Code, authorizes

the use of pharmacy technicians in community pharmacies. It

provides as follows:

Pharmacy technicians may assist a Florida

licensed pharmacist in performing

professional services within a community

pharmacy or institutional pharmacy

environment provided that no licensed

pharmacist shall supervise more than one

pharmacy technician unless otherwise

permitted by the Florida Board of Pharmacy.

A pharmacist's supervision of a pharmacy

technician in a 1:1 ratio working

environment requires that a pharmacy

technician be under the direct and

immediate personal supervision of a Florida

licensed pharmacist. All pharmacy

technicians shall identify themselves as

pharmacy technicians by wearing a type of

identification badge that is clearly

visible which specifically identifies the

employee by name and by status as a

"pharmacy technician", and in the context

of telephone or other forms of

communication, pharmacy technicians shall

state their names and verbally identify

themselves (or otherwise communicate their

identities) as pharmacy technicians.

Pursuant to the direction of the licensed

pharmacist, pharmacy technicians may engage

in the following functions to assist the

licensed pharmacist:

(1 ) Prepackaging and labeling of unit and

multiple dose packages pursuant to

appropriate procedures. The pharmacist

shall directly supervise and conduct in-

process and final checks, and affix his/her

initials to the record. Such pharmacy

technician activities would include the

maintenance of control records ;

(2 ) Assist the pharmacist in the

preparation of the prescription. Such

pharmacy technician functions include the

typing of prescription labels on a

typewriter or through entry into a computer

system and the entry of prescription

information or physicians' orders into a

computer system. The pharmacist, however,

must complete the dispensing act and

initial the prescription ;

(3 ) Assist in the preparation of products

in a pharmacy where such products are not

directly dispensed and administered to the

patient and when done pursuant to

appropriate procedures under the direct and

immediate supervision of a pharmacist who

shall conduct in-process and final checks;

(4 ) Issue supplies and other products from

an institutional pharmacy to physicians,

nursing homes, and other departments in

institutions, pursuant to appropriate

procedures;

(5 ) Initiate a phone call to a prescribing

practitioner or their medical staffs (or

agents) regarding patient prescription

refill authorization requests. Such

pharmacy technician activities allow

initiating calls to the practitioner or

agent, communicating the refill request and

confirming the patient's name, medication,

strength, quantity, directions and date of

last refill. Any response to the above

refill request that indicates a change in

the order must be directly received by the

pharmacist and/or pharmacy intern.

2/ All such original prescriptions filled at Eckerd

Corporation pharmacies are retained for a period of seven

years. (Rule 64B16-28.140(1)(d), Florida Administrative Code,

requires that "[a ] ll original prescriptions . . . be retained

for a period of not less than two years from the date of last

filing.")

3/ This "out-of-court" statement made by Dr. Pomeranz (who

did not testify at the final hearing) is the only record

evidence supporting the allegation made in the Administrative

Complaint that Prescription Number 6071853 (a copy of which

was not offered into evidence at the final hearing) "called

for" 15 milligram, not 180 milligram, tablets of Thyroid.

4/ H. V., like Dr. Pomeranz, did not testify at the final

hearing.

5/ Sections 465.019(6) and 465.025, Florida Statutes, provide

as follows:

465.019 Institutional pharmacies;

permits.-- . . . .

(6 ) In a Class II institutional pharmacy,

an institutional formulary system may be

adopted with approval of the medical staff

for the purpose of identifying those

medicinal drugs and proprietary

preparations that may be dispensed by the

pharmacists employed in such institution. A

facility with a Class II institutional

permit which is operating under the

formulary system shall establish policies

and procedures for the development of the

system in accordance with the joint

standards of the American Hospital

Association and American Society of

Hospital Pharmacists for the utilization of

a hospital formulary system, which

formulary shall be approved by the medical

staff.

465.025 Substitution of drugs.--

(1 ) As used in this section:

(a) "Brand name" means the registered

trademark name given to a drug product by

its manufacturer, labeler, or distributor.

(b) "Generically equivalent drug product"

means a drug product with the same active

ingredient, finished dosage form, and

strength.

(c) " Prescriber" means any practitioner

licensed to prescribe medicinal drugs.

(2 ) A pharmacist who receives a

prescription for a brand name drug shall,

unless requested otherwise by the

purchaser, substitute a less expensive,

generically equivalent drug product that

is:

(a ) Distributed by a business entity doing

business, and subject to suit and service

of legal process, in the United States; and

(b ) Listed in the formulary of generic and

brand name drug products as provided in

subsection (5) for the brand name drug

prescribed, unless the prescriber writes

the words "MEDICALLY NECESSARY," in her or

his own handwriting, on the face of a

written prescription or unless, in the case

of an oral prescription, the prescriber

expressly indicates to the pharmacist that

the brand name drug prescribed is medically

necessary.

(3)(a ) Any pharmacist who substitutes any

drug as provided in subsection (2) shall

notify the person presenting the

prescription of such substitution, together

with the existence and amount of the retail

price difference between the brand name

drug and the drug substituted for it, and

shall inform the person presenting the

prescription that such person may refuse

the substitution as provided in subsection

(2).

(b ) Any pharmacist substituting a less

expensive drug product shall pass on to the

consumer the full amount of the savings

realized by such substitution.

(4 ) Each pharmacist shall maintain a

record of any substitution of a generically

equivalent drug product for a prescribed

brand name drug as provided in this

section.

(5 ) Each community pharmacy shall

establish a formulary of generic and brand

name drug products which, if selected as

the drug product of choice, would not pose

a threat to the health and safety of

patients receiving prescription medication.

In compiling the list of generic and brand

name drug products for inclusion in the

formulary, the pharmacist shall rely on

drug product research, testing,

information, and formularies compiled by

other pharmacies, by states, by the United

States Department of Health, Education, and

Welfare, by the United States Department of

Health and Human Services, or by any other

source which the pharmacist deems reliable.

Each community pharmacy shall make such

formulary available to the public, the

Board of Pharmacy, or any physician

requesting same. This formulary shall be

revised following each addition, deletion,

or modification of said formulary.

(6 ) The Board of Pharmacy and the Board of

Medicine shall establish by rule a

formulary of generic drug type and brand

name drug products which are determined by

the boards to demonstrate clinically

significant biological or therapeutic

inequivalence and which, if substituted,

would pose a threat to the health and

safety of patients receiving prescription

medication.

(a ) The formulary may be added to or

deleted from as the Board of Pharmacy and

the Board of Medicine deem appropriate.

Any person who requests any inclusion,

addition, or deletion of a generic drug

type or brand name drug product to the

formulary shall have the burden of proof to

show cause why such inclusion, addition, or

deletion should be made.

(b ) Upon adoption of the formulary

required by this subsection, and upon each

addition, deletion, or modification to the

formulary, the Board of Pharmacy shall mail

a copy to each manager of the prescription

department of each community pharmacy

licensed by the state, each nonresident

pharmacy registered in the state, and each

board regulating practitioners licensed by

the laws of the state to prescribe drugs

shall incorporate such formulary into its

rules. No pharmacist shall substitute a

generically equivalent drug product for a

prescribed brand name drug product if the

brand name drug product or the generic drug

type drug product is included in the said

formulary.

(7 ) Every community pharmacy shall display

in a prominent place that is in clear and

unobstructed public view, at or near the

place where prescriptions are dispensed, a

sign in block letters not less than 1 inch

in height which shall read: "CONSULT YOUR

PHARMACIST CONCERNING THE AVAILABILITY OF A

LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG

AND THE REQUIREMENTS OF FLORIDA LAW."

(8 ) The standard of care to be applied to

the acts of any pharmacist performing

professional services in compliance with

this section when a substitution is made by

said pharmacist shall be that which would

apply to the performance of professional

services in the dispensing of a

prescription order prescribing a drug by

generic name. In no event when a

pharmacist substitutes a drug shall the

prescriber be liable in any action for

loss, damage, injury, or death to any

person occasioned by or arising from the

use or nonuse of the substituted drug,

unless the original drug was incorrectly

prescribed.

6/ Mr. Lamattina gave the following testimony on the subject:

CROSS-EXAMINATION

BY MS. BASS: . . . .

Q. So it's possible that, while my

initials are on that prescription, somebody

else could have filled that prescription

[the June 18 prescription]?

A. Very possible.

MS. BASS : That's all the questions I have.

REDIRECT EXAMINATION

BY MR. KRANERT:

Q. How would that have happened?

A. You come in the middle of the day, and

someone else has been filling -- another

pharmacist is in charge, but has a backlog

of prescription labels in baskets.

You're given a basket, it has the label in

the basket, sometimes it has the drug. You

read the -- and the prescription, you read

the prescription, you read the label, you

put together the prescription, and out it

goes.

It does have the other pharmacist's, who is

in the computer at the time, initials on

the label.

Q. Now as described to you, this

particular label does not have another

pharmacist's initial[s] on the label?

A. No it doesn't.

Q. It -- it has Ms. Bass' initial[s] on

the label?

A. That's correct.

Q. So Ms. Bass and/or her technician for

this original prescription was responsible

for not only the filling, but the

verification of the completed product

before it was delivered to the patient.

A. I can't say that, because some other

pharmacist may have come in and filled it,

even though this was in a basket to be

filled . . . - - I can't tell you that she

filled the prescription. . . .

RE-CROSS-EXAMINATION

BY MS. BASS:

Q. But it is possible that the pharmacist

who actually filled that prescription could

be somebody other than M[C ]B; is that not

correct?

A. The pharmacist who actually counted the

pills, labeled it --

Q. Did -- did --

A. -- looked at the original prescription

if it was there, could be someone else,

yes.

MS. BASS : That's it.

FURTHER REDIRECT EXAMINATION

BY MR. KRANERT:

Q. Why would their labels not appear --

their initials not appear on the label?

A. Because when the label was typed they

were not in the computer. . . .

FURTHER CROSS-EXAMINATION

BY MS. BASS:

Q. But that pharmacist that filled that

prescription does not -- would not

necessarily have been the name on the

label?

A. That is correct.

Q. Is it not true that you come in some

days and there are baskets sky high --

A. Correct.

Q. -- and they have somebody else's

initials on them?

A. That's correct.

Q. And you fill them and send them on

their way.

A. That's correct.

Q. So the prescription -- the -- the

pharmacist's name on the label is not

yours?

A. The initials printed by the computer

don't necessarily have to be mine, even

though I filled the prescription, and

that -- . . . .

7/ "'Hearsay' is a statement, other than one made by the

declarant while testifying at the trial or hearing, offered in

evidence to prove the truth of the matter asserted." Section

90.801(1)(c), Florida Statutes.

COPIES FURNISHED:

Lawrence F. Kranert, Jr., Esquire

Agency for Health Care Administration

Fort Knox Building

2727 Mahan Drive

Tallahassee, Florida 32308

Marlene Bass, R.Ph .

3000 North Ocean Drive, No. 9G

Riviera Beach, Florida 33404

John Taylor, R.Ph., Executive Director

Board of Pharmacy

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

Theodore M. Henderson, Agency Clerk

Department of Health

4052 Bald Cypress Way

Bin A00

Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this recommended order. Any

exceptions to this recommended order should be filed with the

agency that will issue the final order in this case.